A Phase 3 interventional study of Dexmedetomidine and Ketamine in Postoperative Analgesia and Postoperative Pain Management, sponsored by Zagazig University. Not yet recruiting. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Zagazig University · Phase 3, Interventional, and Prevention
In this study the participants aim to Compare The Effect of Intravenous Combination Dexmedetomidine _ Ketamine versus Dexmedetomidine on Post-Operative Analgesia In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg/kg diluted with normal saline to a volume of 10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg/kg/h infusion and Intravenous ketamine (drug 2) loading dose of 0.2mg/kg diluted with normal saline to a volume of 10 ml solution over 2-3min ( started when a sensory level of T10 was achieved) maintenance dose of 0.2 mg/kg/h infusion. In both groups, drug 1 will be titrated by 0.1 µg/kg/h every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4. If the RSS score was \>4 at 0.2 µg/kg/h of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.
Drug: Dexmedetomidine · Drug: Ketamine
Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg/kg diluted with normal saline to a volume of10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg/kg/h and intravenous normal saline (drug 2) loading dose 10ml of solution over 2-3min ( started when a sensory level of T10 was achieved) and a maintenance dose of 0.2 mg/kg/h as placebo. In both groups, drug 1 will be titrated by 0.1 µg/kg/h every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4. If the RSS score \>4 at 0.2 µg/kg/h of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.
Drug: Dexmedetomidine · Drug: Saline (0.9% NaCl)
Intravenous dexmedetomidine 0.5 µg/kg diluted with normal saline to a volume of 10 ml solution over 10 min followed by 0.5 µg/kg/h infusion.
Intravenous ketamine 0.2 mg/kg diluted with normal saline to a volume of 10 ml solution over 2-3 min followed by 0.2 mg/kg/hr infusion.
intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg/kg/hr infusion as placebo
Assess the postoperative analgesic requirements in first 24 hours.
Pain will be assessed and recorded using visual analogue scale (VAS) {0=no pain, 1 to 3 = mild pain, 4 to 6 = moderate pain, 7 to 10 = severe pain} immediately on arrival to PACU then at 2, 4, 6,12, 24 hours after surgery by an observer blinded to treatment groups. • On the first analgesic demand or when VAS scale 1-3, diclofenac 75 mg IV will be given. nalbupine 20 mg IV will be administered as a rescue analgesic, as needed if the VAS scale 4-10 .
Time frame: Pain grade of patients will be evaluated immediately on arrival to PACU then at 2, 4, 6,12, 24 hours postoperatively
Total amount of rescue analgesic requirement
Total amount of rescue analgesic requirement in first 24 hours Postoperatively
Time frame: In first 24 hours postoperatively
No study locations are listed for this record.
Plan to share: Yes — planned after the completion of the study and publication
Supporting information: Study protocol, Sap, Analytic code
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Zagazig University